A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
NCT ID: NCT04848220
Last Updated: 2023-12-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
29 participants
INTERVENTIONAL
2021-05-20
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Stage A (Dose Cohort 1) and Stage B (Dose Group 1)
Temanogrel
Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)
Stage A (Dose Cohort 2) and Stage B (Dose Group 2)
Temanogrel
Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)
Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2)
Placebo
Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
Interventions
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Temanogrel
Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)
Placebo
Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
Eligibility Criteria
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Inclusion Criteria
* Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography and must satisfy the study criteria regarding lesion size and vessel diameter/type.
* Females must not be of childbearing potential
* Males with pregnant or non-pregnant female partners of childbearing potential must agree to using a condom during treatment and for 90 days following treatment
Exclusion Criteria
* Any history of stroke, seizure, intracranial bleeding, or intracranial aneurysm
* Transient ischemic attack within the 6 months prior to Screening
* History of major trauma, major surgery, and/or clinically significant head injury or hemorrhage within the last 6 months of Screening
* Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI within the target vessel territory within the last 4 months of Screening
30 Years
80 Years
ALL
No
Sponsors
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Arena is a wholly owned subsidiary of Pfizer
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Tibor Rubin VA Medical Center
Long Beach, California, United States
VA Palo Alto - Cardiac Catheterization Laboratory
Palo Alto, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Alfred Health - The Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Maasstad Hospital
Rotterdam, South Holland, Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Skåne University Hospital
Lund, , Sweden
East and North Hertfordshire NHS Trust Lister Hospital
Stevenage, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5071002
Identifier Type: OTHER
Identifier Source: secondary_id
APD791-202
Identifier Type: -
Identifier Source: org_study_id